- Company reached alignment with the U.S. FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn® in ALS - SPA in place for Phase 3b NurOwn® trial in ALS - Enhanced leadership team with appointment of Hartoun Hartounian Ph.
D. as EVP and Chief Operating Officer, and promotion of Dr. Bob Dagher to EVP and Chief Medical Officer - Conference call and webcast at 8.
30am ET today NEW YORK , Aug. 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI ), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the Second Quarter ended June 30, 2023 and provided a corporate update.
"We continue to make excellent progress in our preparations for the planned Phase 3b trial of NurOwn in ALS, with important recent developments on regulatory and operational fronts," said Chaim Lebovits , President and CEO of BrainStorm. "We believe that the regulatory aspects of the program have been substantially derisked, having secured agreement with the FDA on a Special Protocol Assessment and also reached alignment on the CMC aspects. We have selected a leading Clinical Research Organization and are actively working to establish multiple trial sites.
If successful, this trial has the potential to significantly improve the lives of ALS patients by providing a much-needed therapeutic option." Second Quarter 2024 and Recent Highlights Clinical and regulatory In Ju.